Please Wait a Moment
X

Articles

04Jan

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma

04 Jan, 2022 | Return|

On December 28, 2021, the FDA updated the emergency use authorization  (EUA) for COVID-19 convalescent plasma.  The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment.  Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA define acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.

We are currently evaluating our options to determine if we can provide additional testing services using one of the newly defined assays. Please reach out to your customer service manager if your organization is considering CCP testing under the updated guidelines. 

 

 

 

Related

CTS Dallas and Phoenix Labs Implements WNV Testing on the Panther

CTS Dallas and Phoenix Labs successfully implemented WNV NAT testing on the Panther Testing Platform...

Read More >

Shipping conditions for Monolisa anti-HBs EIA

After a recent reevaluation of the Monolisa anti-HBs EIA package insert, the CTS QA/Scientific team ...

Read More >

Join us for a Babesia webinar!

As communicated on January 21, 2020, CTS will implement the licensed Grifols Babesia test for sample...

Read More >

Reminder- Check flights and cargo hours for the New Year holiday

As a friendly reminder, airlines often change their routine flights and cargo hours for hol...

Read More >

Pooled Zika Testing and New CTS Website Functionality- November 29th Update

As previously mentioned in Zika communications distributed on September 21 and October 12, 2018; ord...

Read More >

Notification of Form Revisions to Implement on September 2, 2019

The CTS forms listed below have been revised with an implementation date of September 2, 2019. ...

Read More >